Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water

Forms and Documents

Document Name	Status
0658 Bottled Water SSA 2019 Ext.pdf Supporting Statement A	2019-04-01

IC Document Collections

IC ID	Document Title	Status
191477	bottlers rectifying contamination	Removed
191476	bottlers conducting secondary testing of source water	Removed
191475	bottlers testing finished product only	Removed
191474	RECORDKEEPING: Processing and Bottling of Bottled Drinking Water	Modified

ICR Details

OMB Control No: 0910-0658	ICR Reference No: 201903-0910-002
Status: Active	Previous ICR Reference No: 201603-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2019
	Date Received in OIRA: 04/02/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved	04/30/2019
Responses	2,223	0	2,223
Time Burden (Hours)	179	0	179
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires recordkeeping by respondents who process or sell bottled water in the United States to demonstrate that their products comply with applicable testing requirements. The regulations are intended to ensure the safety of bottled water made available for human consumption.

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Authorizing Statute(s): US Code: 21 USC 349 Name of Law: FFDCA; Bottled Drinking Water Standards
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 55726	11/07/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 11985	03/29/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
bottlers testing finished product only
bottlers conducting secondary testing of source water
bottlers rectifying contamination
RECORDKEEPING: Processing and Bottling of Bottled Drinking Water

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,223	2,223	0	0	0	0
Annual Time Burden (Hours)	179	179	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Our review shows the information collection remains constant and we have therefore retained the currently approved burden estimate. At the same time, we have consolidated the 4 ICs previously appearing at omb.report into one IC to reflect the cumulative burden for the recordkeeping provisions under 21 CFR part 129.

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Annual Cost to Federal Government: $51,308

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/02/2019

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